Recall Z-1938-2019
Cardiac Science Corporation · initiated June 4, 2019
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
Powerheart G5 Automatic AED
Codes / lots: Model Number G5A 80A; AED Serial Number (UDI Number): D00000133922 )(01)00812394021222(11)190508(21)D00000133922), D00000133927 ((01)00812394021222(11)190509(21)D00000133927), D00000133930 ((01)00812394021222(11)190509(21)D00000133930), D00000133934 ((01)00812394021222(11)190509(21)D00000133934), D00000133936 )(01)00812394021222(11)190509(21)D00000133936).
Reason for recall
Sub-supplier s documentation for specific Printed Circuit Boards (PCB) is insufficient to determine if the devices conform to specifications.
FDA-determined cause: Process control
Action taken
Cardiac Science Corporation notified customers of the recall on about 06/04/2019 via phone call and "URGENT: VOLUNTARY MEDICAL DEVICE RECALL" letter. Customers were instructed to examine inventory, remove any affected devices, and contact Cardiac Science immediately to arrange for return of affected devices and replacement of new devices. Contact can be made by phone to 800.426.0337 option 1 or by email at techsupport@cardiacscience.com. Distributors were instructed to determine who received the affected devices, inform customers that a Cardiac Science representative will contact them and provided a list with customer names, contact information (including phone and email addresses) and affected device serial numbers to Cardiac Science. The list can be provided by calling 800.426.0337 or by emailing it to techsupport@cardiacscience.com.
Details
- Recall number
- Z-1938-2019
- Initiated
- June 4, 2019
- Terminated
- November 15, 2021
- Product code
- MKJ – Automated External Defibrillators (Non-Wearable)
- Quantity
- 5 devices
- Distribution
- US distribution to Georgia, Texas, and Wisconsin.
- Recalling firm
- Cardiac Science Corporation, Deerfield, WI